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THE PHARMA REVIEW (NOVEMBER - DECEMBER 2011)

Paracetamol - Safe and Effective Use

Anoop P*, Selvamuthu kumaran S1, Manna P K, G P, Mohanta

Abstract: Paracetamol chemically known as N-Acetyl-p-Aminophenol (APAP or Acetaminophen) is one of the most widely used and perceived as safe medication. The drug is so illustrious that even a layman doesn’t need any introduction about it because it is the first drug of choice for fever and pain. It is available as a single drug or in combination with other analgesics. The drug is a wonder when used under the prescribed limit. It is available with prescription and also as an over the counter (OTC) drug which is the predominant cause for its wide use. The maximum recommended dose for an adult in a day is 4gms and 200mg/kg for a child. The dose is not ecumenical, as it changes from person to person, especially if the person has increased sensitivity, liver disease or is an alcoholic, for whom the drug under normal doses cause’s toxic effects. Unsupervised or over dosage administration of the drug induces liver failure eventually causing death. This increased toxicity report of paracetamol has made USFDA to issue warning on its use. The main toxicity is the liver failure due to release of a toxic hepatotoxic metabolite. Even though the epidemiology of liver failure in India due to paracetamol is less compared to the western countries, proper patient education should be done regarding its use. The pharmaceutical companies along with the regulatory bodies in India should propose new labeling directions for the proper use of the product. The physicians and the pharmacists must play a major role in educating the patient about the overdose complications which rescues the consumer from its toxicity.

 
History of The Drug20 In 1893, the white, odorless crystalline compound with a bitter taste that became known as paracetamol was discovered. This happened at University of Strasburg when Professor Adolf Kussmaul, Department of Internal Medicine, asked two young assistants, Arnold Cahn and Paul Hepp, to treat patients with naphthalene as it had been used elsewhere as an internal antiseptic. The medicine had little effect on worms, but, paracetamol was found in the urine of patients who had taken phenacetin, who had a great reduction in fever temperature.
In 1887, the Bayer Company introduced the 4-ethoxy derivative, phenacetin, as a less toxic analogue of acetanilide. Phenacetin was widely used for about 90 years until mounting concerns over carcinogenicity and kidney damaging properties. In 1889 it was demonstrated that paracetamol was a urinary metabolite of acetanilide.
The use of paracetamol was first reported in 1893 by von Mehring who concluded that because of its hematological side effects of methaemoglobinaemia, It 1948-1949, Brodie and Axelrod discovered that paracetamol was the main metabolite of both acetanilide and phenacetin, that paracetamol experienced a resurgence of interest.
In 1950 the first paracetamol product, a combination of paracetamol, aspirin and caffeine was on the United States market under the name Triagesic, was on the United States market under the name Triagesic, but was later discontinued as it was alleged to cause blood related disorders. Again in 1955, paracetamol was back in the American market when the allegation was proved wrong. In 1956, 500 mg tablets of paracetamol went on sale in the United Kingdom and its popularity as an over-the-counter analgesic rapidly increased.

 

 

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